Informations générales (source: ClinicalTrials.gov)
Percutaneous Treatment of Iatrogenic False Femoral Aneurysms by Ultrasound-guided Thrombin Injection (EGTI)
Observational
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
décembre 2020
décembre 2023
29 juin 2024
Since the 2000s, endovascular procedures have been expanding rapidly in multiple
disciplines: cardiology, radiology, interventional neuroradiology, and of course vascular
surgery. Most procedures are performed by puncture of the common femoral artery with
introducers ranging in size from 4F to 26F for aortic procedures.
The most frequent complications of percutaneous punctures are false femoral aneurysms due
to failure to close the arterial gap (up to 8% in some studies). A false aneurysm is a
pocket of blood communicating with an artery and secondary to the rupture of the arterial
wall. The blood is then contained by the adjacent structures and often a fibrous shell
which distinguishes it from an aneurysm which retains the integrity of its wall.
The management of false femoral aneurysms is variable. Below 2 cm, monitoring may be
performed with or without manual or ultrasound-guided compression. In case of persistence
of the false aneurysm and/or complication, open surgery can be performed.
Endovascular treatment of false aneurysms was first proposed in 1986. Different
endovascular techniques can be proposed to occlude false aneurysms such as the use of
coils, biological glue, the use of arterial closure systems...
Echoguided injection of thrombin to occlude the false aneurysm in a manner has been
published since the late 1990s. The treatment is evaluated as reliable and safe. A recent
article in the EJVES (6) investigates the value of low-dose thrombin for this indication,
and the results appear to be very encouraging for low-dose thrombin in false femoral
aneurysms.
Thrombin injection for the treatment of iatrogenic false femoral aneurysms is the
technique currently favoured by the vascular surgery team at the Paris Saint Joseph
Hospital Group (GHPSJ). Open surgery is a second-line treatment and remains indicated in
case of acute symptoms (radiculalgia, motor/sensory deficits; ischemia, skin necrosis), a
false aneurysm that is too deep or without a neck, an infectious origin or a patient
treated with dabigatran. Patients will be reviewed at 1 and 12 months according to the
usual follow-up.
In this work, investigators will study the efficacy of false aneurysm closure using human
thrombin injection. This work is intended to confirm previous work. A socio-economic
study may be conducted in parallel. Follow-up after the use of percutaneous closure
systems and in the context of bypass surgery may also be of interest.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Yann GOUEFFIC | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient whose age ≥ 18 years
- Patient with iatrogenic false femoral arterial aneurysm, post arterial or venous
puncture, following management for a diagnostic or therapeutic examination.
- Circulating false aneurysm confirmed by an imaging examination (echo-Doppler,
angioscanner; angio-MRI).
- Indication for exclusion of false aneurysm
- False aneurysm treated at GHPSJ between 01/09/2020 and 31/12/2022 by thrombin
injection
- Patient whose age ≥ 18 years
- Patient with iatrogenic false femoral arterial aneurysm, post arterial or venous
puncture, following management for a diagnostic or therapeutic examination.
- Circulating false aneurysm confirmed by an imaging examination (echo-Doppler,
angioscanner; angio-MRI).
- Indication for exclusion of false aneurysm
- False aneurysm treated at GHPSJ between 01/09/2020 and 31/12/2022 by thrombin
injection
- Patient under guardianship or curatorship
- Patient under court protection
- Patient objecting to the use of his/her data for this research